NCT00413517已完成不适用
Evaluation of Epi-lasik in U.S. Army Personnel
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 150
- 试验地点
- 2
- 主要终点
- Safety and efficacy of Epi-LASIK
研究概览
简要总结
The purpose of this study is to evaluate the safety and efficacy of Epi-Lasik in U.S. Army personnel who have naturally occurring myopia with or without astigmatism. The data from this control group will be collected in such a way as to be comparable to data sets from study groups undergoing wavefront guided PRK, conventional PRK, and related laser refractive surgery procedures.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Active duty US Army Soldiers eligible for care at WRAMC
- •Male or female, of any race, and at least 21 years old at the time of the pre-operative examination, and have signed an informed consent. The lower age limit of 21 years is intended to ensure documentation of refractive stability.
- •Manifest refractive spherical equivalent (MSE) of up to 6.00 diopters (D) at the spectacle plane with refractive cylinder up to 3.00 D.
- •Manifest refraction and LADARWave™ refractions must be within 1.00 D.
- •Best spectacle corrected visual acuity of 20/20 or better in both eyes.
- •Demonstrated refractive stability, confirmed by clinical records. Neither the spherical nor the cylindrical portion of the refraction may have changed more than 0.50D during the 12-month period immediately preceding the baseline examination, as confirmed by clinical records.
- •Soft contact lens users must have removed their lenses at least 2 weeks before baseline measurements. Hard contact lens users (PMMA or rigid gas permeable lenses) must have removed their lenses at least 4 weeks prior to baseline measurements and have 2 central keratometry readings and 2 manifest refractions taken at least 1 week apart that do not differ by more than 0.50 D in either meridian; mires should be regular.
- •Subject must expect to be located in the greater Washington DC area for a 12 month period post-operatively.
- •Consent of the subject's command (active duty) to participate in the study.
- •Access to transportation to meet follow-up requirements
排除标准
- •Female subjects who are pregnant, breast-feeding or intend to become pregnant during the study. Female subjects will be given a urine pregnancy test prior to participating in the study to rule out pregnancy. [Pregnancy and breastfeeding are contraindications to refractive surgery in general, including epi-lasik, whether participating in this study or not]
- •Concurrent topical or systemic medications that may impair healing, including corticosteroids, antimetabolites, isotretinoin (Accutane), amiodarone hydrochloride (Cordarone) and/or sumatripin (Imitrex).
- •Medical condition(s), which, in the judgment of the investigator, may impair healing, including but not limited to: collagen vascular disease, autoimmune disease, immunodeficiency diseases, and ocular herpes zoster or simplex.
- •Active ophthalmic disease, neovascularization of the cornea within 1mm of the intended ablation zone, or clinically significant lens opacity.
- •Evidence of glaucoma or an intraocular pressure greater than 22 mm Hg at baseline.
- •Evidence of keratoconus, corneal irregularity, or abnormal videokeratography in either eye.
- •History of recurrent erosions or epithelial basement dystrophy.
- •Patients with known sensitivity or inappropriate responsiveness to any of the medications used in the post-operative course.
- •Any physical or mental impairment that would preclude participation in any of the examinations.
结局指标
主要结局
Safety and efficacy of Epi-LASIK
时间窗: 12 months after procedure
次要结局
未报告次要终点
研究者
研究点 (2)
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